Research Advisory Committee on GW Illness Chairman explains how Institute of Medicine was Made to Perform Studies Whose Conclusions Were Predetermined

Jim Binns, chairman of VA's Research Advisory Committee on GW Veterans' Illnesses since its inception, authored a detailed memo, with supporting documents, to show how Congress' statutory charge to the IOM was changed to exclude animal studies and raise the bar for granting presumptive disabilities to ill Gulf War veterans.

Jim deserves enormous thanks for his tireless pursuit of fairness for ill veterans, and his methodical discussion of how a series of mostly useless IOM reports came to be produced.

Army Nearly Done With Probe of Fort Detrick Lab/ Wash Post

No Signs of Criminal Misconduct Found Yet in Disappearance of Virus, Official Says

This rather inconsequential article (lacking context) says Fort Detrick is still working on its inventory...going on 3 months now? Not surprisingly, the Army hasn't found anything to be concerned about, according to Fort Detrick's PR person. The article implies that much of the base's research remains on hold.

Despite fines and sanctions at other research institutes for safety lapses, I have never heard of a single research center that basically shut down for weeks or months pending a review. That back story--what it took to shut the place down, and whether it relates to the anthrax letters--could be extremely interesting.

The 2008 Naval Environmental Health Center Study by Dr. Margaret Ryan et al. on anthrax vaccination during pregnancy: a critique and historical review

Comments on: Ryan, MAK, et al. Birth Defects among Infants Born to Women Who Received Anthrax Vaccine in Pregnancy. American Journal of Epidemiology; July 2008.

Meryl Nass, MD

April 20, 2009

Dr. Margaret AK Ryan reports that of the 95,595 military women who delivered babies between 1998 and 2004, anthrax vaccine (one dose or more) was given to 3,465 military women during their first trimester of pregnancy. Dr. Ryan, a physician epidemiologist and Navy Commander, has studied these women for the past eight years, and published results in 2008.

The Original Study Led to Major Policy Changes

Dr. Ryan presented results of a subset of this group (those vaccinated 1998 through mid 2001) in late 2001 and early 2002. Shortly after her presentation to FDA, in January 2002 FDA changed the pregnancy warning on the anthrax vaccine label to category D from C, indicating that data showed the vaccine was associated with birth defects, and should not be given to women during pregnancy. The Assistant Secretary of Defense for Health Affairs, Dr. William Winkenwerder, also responded to Dr. Ryan's findings. He sent memos to all the military services, directing that special efforts should be made to avoid giving the vaccine during pregnancy, including the use of pregnancy tests if appropriate.

[He was reacting to the increased rate of birth defects, but also to the relatively high rate of first trimester vaccinations. Before 2002, military medical professionals tended to vaccinate women who thought they might be pregnant but had no proof. Fortunately, that changed after Dr. Ryan's 2001 preliminary report. A much smaller number of women with first trimester pregnancies have been vaccinated since.]

Her 1998-2001 study data were shared with the Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine and with the Armed Forces Epidemiology Board, as well as FDA. When initially presented, the study compared first trimester-vaccinated women to women who had been vaccinated at any other time. The data showed a reportedly small increase in birth defects in offspring of first trimester-vaccinated women, yet the increase was statistically significant. For some reason, these data were never published, despite the effect they had on both vaccination policy for military women, and changing the pregnancy warning on the vaccine label.

Expanding the Dataset but Reducing Statistical Significance

Subsequently, Dr. Ryan et al. added to the original data collection, extending the period of births through 2004. In 2008, Dr. Ryan published these data, discussing the original comparison between first trimester-vaccinated mothers and mothers vaccinated at another time, but the published paper also compared these births to births in mothers never vaccinated against anthrax.

This expanded dataset yielded a smaller difference in birth defect rates in offspring between first trimester-vaccinated women and those vaccinated at any other time, which was only statistically significant when offspring of first trimester-vaccinated women were compared with offspring of those never vaccinated.

In February 2002 it was reported (in the CDC’s Morbidity and Mortality Weekly Report: MMWR 127 vol 51 No. 6: Notice to Readers: Status of US Department of Defense preliminary evaluation of the association of anthrax vaccination and congenital anomalies) that investigators were conducting a systematic evaluation of original (paper) medical records of women who received anthrax vaccine to determine how well the electronic medical data agreed with the (paper) medical records.

In 2008, Dr. Ryan described significant problems with the electronic data that she used. Her published paper states that only “a subset of women whose data were archived after they left military service” had their hard-copy data compared with the electronic database. Hardcopy records were reviewed for 11,271 of the 95,595 women who gave birth during the study period, and “were more likely from women who gave birth earlier in the observation period and left military service soon after” and “did not represent a random sample.”

Of the 11,271 women whose paper records were reviewed, 1,318 had anthrax vaccinations recorded on paper. Of these 1,318, only 1,158 had anthrax vaccination recorded electronically. “When compared with those of [paper] medical records, the specificity of electronic data was 97.5%, and the sensitivity was 61.5% for correctly identifying [anthrax] vaccine recipients.” This means very few women whose paper records showed they did not get the vaccine were identified electronically as having received it, but that many who did receive it, according to their paper medical records, failed to have the vaccinations recorded electronically.

Could it be that the poorer sensitivity (ability to correctly identify those who received the vaccine) of the electronic database contributed to the drop in birth defect rates in offspring of those vaccinated women added to the database later? Given the demonstrated low sensitivity of the electronic record for identifying vaccinations, it is very likely that some of the women who had infants with birth defects failed to have their vaccinations accurately recorded in the electronic database. Since electronic records supplied more of the study data for women vaccinated later compared to earlier, relatively more late-vaccinated women would be expected to be incorrectly placed in the unvaccinated group. This could dilute the measured adverse vaccine effect in infants born later, compared with the data used in Ryan’s earlier assessment.

In other words, the greater use of the more accurate paper records, for those vaccinated earlier, would be expected to result in more accurate vaccination ascertainment for mothers of infants with birth defects who were born earlier.

Merging data from both paper and electronic records, despite low sensitivity for identifying anthrax vaccinations in the electronic records, is a major problem with this study. It may have led to loss of statistical significance for some comparisons despite a larger number of subjects in the later study.

Biologic Plausibility of Vaccine-Induced Birth Defects

Dr. Ryan stated that, “there is little information available to support biologic plausibility of anthrax vaccine as being teratogenic.” The CDC’s Morbidity and Mortality Weekly report, cited earlier, reported that, “although the Food and Drug Administration-licensed vaccine has not been suspected to be a hazard to reproductive health, no studies of animals or pregnant women have been conducted.” Shouldn’t studies in pregnant animals have been required prior to mandatory use of the vaccine in the young female military population? Then again, if no animal studies had been conducted, it was easy to say there was no information linking the vaccine to birth defects.

The anthrax vaccine contains formaldehyde, aluminum, benzethonium, 3 anthrax toxins that are known to exert profound biologic effects, and an array of uncharacterized substances derived from anthrax fermentation. Why is it implausible to think that injecting this mix might contribute to birth defects?

Dose-Response Relationship

Is there a dose-response effect from anthrax vaccine on the rate of birth defects, as might be expected if the vaccine were truly causing such problems? Ryan et al. state that “infants exposed to two or more maternal anthrax vaccine doses in the first trimester did not have a significantly increased risk of birth defects,” implying that there was no dose-response relationship.

But a positive dose-response relationship did exist. Infants exposed to two or more vaccine doses in the first trimester had an adjusted rate of birth defects 1.19 times higher than infants of mothers vaccinated at another time. But a smaller number of infants received 2 or more vaccinations prior to detecting a pregnancy, rather than just one, so this increased rate did not achieve statistical significance. More infants of multiply-vaccinated first trimester mothers would have been needed to achieve statistical significance.

Birth Defect Rates

In the US overall, 3.0% of infants are born with a significant birth defect. However, in military women vaccinated outside the first trimester, 4.2% of offspring had at least one major birth defect. In never-vaccinated women, 4.03% of offspring had a birth defect. In those vaccinated during the first trimester, 4.7% had at least one major birth defect.

When 4.7% is compared to 4.2%, the increase in the birth defect rate is only 12%. But consider the vaccine's makeup. Anthrax vaccine uses the aluminum adjuvant Alhydrogel to create a depot effect, slowly releasing vaccine antigen over some months following an injection. So women vaccinated prior to the first trimester could still be exposing their fetus to the vaccine. That is why they should not have been included in the control group: at least, those vaccinated in the year prior to conception should not have been used as controls.

Ryan’s data support the hypothesis of pre-pregnancy vaccination contributing to birth defects. In women vaccinated during the first trimester, the birth defect rate in offspring was 4.68%. In offspring of women vaccinated prior to pregnancy, the birth defect rate in offspring was 4.56%: nearly as high. In those vaccinated after pregnancy, the birth defect rate in offspring was only 3.85%.

By including pre-pregnancy vaccinations in the original control group, the effect of the vaccine on birth defect rates was diluted.

Now compare birth defect rates of infants born to women given anthrax vaccine during their first trimester with all infants born in the United States. When you compare 4.7% to 3.0% (the rate of major birth defects diagnosed in the first year for all infants) the unadjusted increase in the birth defect rate is 57%. This suggests that the increase in birth defects attributable to anthrax vaccine could be quite considerable. (However, these numbers have not been adjusted to take account of other possible differences between the two populations. On the other hand, military populations are considered healthier, on average, than their civilian counterparts, so the comparison is probably fair.)

Conclusions

In the 2008 paper’s conclusions, Dr. Ryan et al. note that additional research should be done, and make the excellent suggestion to perform active follow-up, such as that being performed by the Smallpox Vaccine in Pregnancy Registry. Ryan et al. also point out that potential adverse effects of vaccinations given pre-conception should be assessed.

But the sentence immediately following this recommendation states incorrectly that, “these analyses found no evidence that prepregnancy maternal anthrax vaccination is associated with an increased risk for birth defects.” Maybe the relationship was not significant, but the rate was considerably higher than for offspring of military women never vaccinated, of military women vaccinated postpregnancy, and for offspring of American women overall.

Ryan’s final sentence makes this reasonable point: “… women with no known exposure to inhalation anthrax should continue to avoid anthrax vaccination during pregnancy.”Overall, the data presented by Ryan et al. give cause for concern, and should provide the impetus to further study the issue of anthrax vaccine and birth defects. Most importantly, these data tell us that the military’s electronic database has serious flaws, and requires enhanced data entry and ongoing testing to assess the validity of the information it contains.

For future study of the effects of anthrax vaccine in pregnancy, paper records should be used. Furthermore, women receiving pre-pregnancy vaccinations, who were shown to have high rates of infants with birth defects, cannot be used as the control group in a scientifically valid study. Finally, an understanding of how and why birth defects rates in the offspring of military women exceed civilian rates must be sought.

Redesigning Healthcare: Don't Miss This Reinhardt Gem!

Uwe Reinhardt, Princeton's healthcare economist who has previously been featured in this blog, has posted a very interesting article to his NY Times blog. In it, he dissects the various roles of the healthcare system, using the German model to explain how some roles can be performed by government and others by private health insurance companies. In the German system, everyone (90%) is covered, all workers and their employers contribute, and social goals are attained, at a cost less than half that in the US. Germans can choose from 200 different health insurance funds to get their health needs met.

Reinhardt has also started talking about one of the (cultural) elephants in the healthcare room. Must it take someone who hails from outside the US to explain to us our cultural biases? One recalls the success of DeToqueville in a similar arena.

Reinhardt spits it out: prevailing views of what our rights should be, vis a vis health care costs and entitlements, is inherently contradictory:

They [health plans in Germany, Netherlands, Switzerland] all rely on purely private, nonprofit or for-profit insurers that are goaded by tight regulation to work toward socially desired ends. And they do so at average per-capita health-care costs far below those of the United States — costs in Germany and the Netherlands are less than half of those here. . .

In Europe, as in Canada, that social ethic [guiding the payment for and provision of healthcare] is based on the principle of social solidarity. It means that health care should be financed by individuals on the basis of their ability to pay, but should be available to all who need it on roughly equal terms. The regulations imposed on health care in these countries are rooted in this overarching principle.

First, these countries all mandate the individual to be insured for a basic package of health care benefits.

Many Americans oppose such a mandate as an infringement of their personal rights, all the while believing that they have a perfect right to highly expensive, critically needed health care, even when they cannot pay for it. This immature, asocial mentality is rare in the rest of the world.

Read the full article, browse his other posts, and be grateful that a few pundits like Reinhardt are pointing to sensible solutions to the health care morass choking our nation.

One step could dramatically improve hospital care and patient safety

Information has many ways of falling through the cracks in hospitals and medical practices.

The wrong test may be mistakenly ordered by the doctor. The ward secretary may order the wrong test. The lab may perform the wrong test, or rarely perform it on the wrong person. The result may not be available until after the patient leaves the hospital, and then gets lost in cyberspace; or it reaches the chart after the doctor has dictated the discharge summary and is never seen.

Usually more than one doctor takes care of each patient, but each may not be aware of everything the other has done, or which tests were ordered and are still pending.

A simple fix would be to require that all electronic medical records systems must be linked to the laboratory and radiology departments, and must be able to generate a list of all tests ordered; their results; and those tests whose results are still pending. At the end of a hospitalization, each doctor would have to sign off on the list, to ensure all tests had been considered.

We currently have a hodge-podge of hundreds of proprietary EMR systems that do not communicate with each other throughout the US, and the system I use does not have this capability.

Electronic medical records are a wonderful idea in theory. In practice, they are fraught with difficulties and potentially may be accessed or "hacked" by unauthorized individuals, making a mockery of patient confidentiality. The problem of confidentiality is central to getting a working EMR system in place throughout the nation, through which doctors and patients can communicate; yet it requires cybersecurity resources beyond the financial resources of hospitals and medical practices in the private sector. This is why the development and maintenance of such a system must be federalized.

MK Shai calls for anthrax vaccine experiment probe

from YNet:

Kadima Knesset Member and former Israeli Defense Force spokesman Nachman Shai on Friday said either a state commission of inquiry or a parliamentary commission of inquiry should be set up to look into the anthrax vaccine experiments conducted on IDF soldiers. MK Shai said, "The fact that the experiment was hidden from the public and the examinees is a moral issue of the highest degree".

More on the Israeli anthrax vaccine experiment on soldiers

From the Jerusalem Post

From the AP

Excerpts from today's Ha'aretz:

Dr. Reuven Porat, who chaired the medical committee, told Haaretz the panel had not been presented with any official documentation that shows the decision to develop, test and produce the vaccine had been authorized by the government. Similarly, there was no authorization presented from the defense minister, who is charged with responsibility for the Institute for Biological Research, and not from the IDF, and there was no proof the chief of staff was consulted about or agreed to the project...

In its report the panel is highly critical of the "secrecy" imposed by the managers of the experiment and ask "whether the secrecy was necessary because the experiment was to be hidden from the Israeli public."

The medical panel noted: "Selecting soldiers as the population for the experiment prevented achieving the declared aim of the experiment, which was to examine its safety and effectiveness in broad use among the general civilian public, the elderly, women, children and sick patients," the committee wrote.

From YNet come these excerpts:

Israel has admitted to developing a vaccine against anthrax, fearing it might be used as a bio-weapon by enemy nations against civilians, and tested it on IDF soldiers. "Once we face a substantial threat, we would be able to vaccinate all citizens, ranging from babies to the elderly, and protect them against the virus," a senior defense source told Ynet. (But the report indicates Israel already had a large enough stock of vaccine for its population prior to beginning this trial--Nass) From PressTV: Some of the soldiers, who say that the experiment has had life-threatening side effects for them are now filing a lawsuit against the Israeli Army, Haaretz reported... Israeli Physicians for Human Rights have also filed a lawsuit against the army over the experiments.

Medical panel: Anthrax experiments on IDF soldiers were unjustified

Another fascinating article on the Israeli anthrax vaccine experiments by Yossi Melman in Haaretz. Excerpts follow. It seems no one in Israel would take any responsibility for the experiment, which is being laid at the feet of (assassinated) former Prime Minister Itzhak Rabin -- but no documentary evidence was given to the Israeli Medical Association committee invesetigating the experiment to support the putative association with Rabin.

In the US, I have been unable to learn who has been behind approval of the anthrax vaccine for mass use, when there exists no experimental evidence for human efficacy, the safety profile is awful, and the need has never been demonstrated.

Following a three-month legal battle in Israel's High Court of Justice, the report was finally approved for publication Wednesday...

The experiments were carried out in light of what was then defined as the "strategic threat of a surprise biological attack facing Israel. However, the report said that it was not clear who the decision makers were who determined the vaccine's necessity...

The Chairman of the medical committee, Dr. Reuven Porat, told Haaretz that the panel was not presented with any official evidence indicating that either the government, the defense minister of the IDF chief of staff had authorized the development, testing, or production of the vaccine...

The report insinuates that it was improper motivation that prompted the launch of the experiments, but it does not specify what these motivations were, saying that the panel "could not make out the true inspiration behind them..."

The report reveals that even while the experiment was taking place Israel already had a stock of vaccines, a fact which further raised the concern that the experiment wasn't necessary; that it was carried out as a result of external pressure. "An accelerated effort to produce large quantities of the vaccine was underway a year prior to the experiment, and by the time the experiments were launched, Israel had enough vaccines to cover the civilian concerns," the report said...

Israel and the IDF accepted the principles of the Helsinki Accords, declaring many times that they meet their standards. In reality, however, the report states that "the military Helsinki committee failed to fulfill its duties in 'Omer 2' in every one of the points examined by the report."

"No scientific justification was found for the experiment, scientific background was lacking, the experiment's design and execution did not suit its goals, and no result would have justified those goals. Also, conventional guidelines were not followed, risks and possible side effects were not thoroughly investigated, and a follow-up mechanism to keep track of participating soldiers was not set up....."

Preventing Bioterrorism (Op/Ed by Rep. Rush Holt)

Preventing bioterrorism:

Thursday, March 12, 2009
BY RUSH HOLT
Last year, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism -- itself an outgrowth of the 9/11 Commission and its recommendations -- issued its report. It used alarming language to prod our government to act. It affirmed something that was demonstrated with the deadly anthrax attacks: Terrorists will likely use WMD attacks on America that feature biological weapons. The question now is: Have we implemented "lessons learned" from these attacks that took place in the fall of 2001, which caused such havoc here in New Jersey and across the nation?

I agree with the commission's assertion that "only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. and global biosecurity." To that end, the commission made a number of recommendations for improving biosecurity here at home, including the more thorough and persistent monitoring of personnel working at high-containment laboratories (i.e., those who work with dangerous pathogens) and the designation of a single federal agency for tracking the number of such labs in the United States.

I support those and other measures, but I do not believe Congress and the incoming administration can craft an effective biosecurity program for our country unless and until we take the time to investigate thoroughly the only major (and still unsolved, according to many) bioterror attack on our country to date.
Last week, I reintroduced the Anthrax Attacks Investigation Act, to examine and to report on how the attacks occurred and how we can best prevent similar episodes in the future.

Readers may wonder why the commission did not address the 2001 anthrax attacks in detail in its report. The answer is that examining those attacks was not an explicit mandate of the WMD Commission. This is in contrast to the 9/11 Commission, which was specifically charged with looking at how the Sept. 11, 2001 attacks happened, why the federal government failed to prevent the attacks, and what remedial measures are necessary to prevent a similar catastrophe in the future.

A thorough investigation into the federal government's response to the first modern bioterror attack on our soil is absolutely essential if we are to ensure that we have learned the right lessons from that episode to implement countermeasures and changes in policy that are directly tied to those "lessons learned" -- something that The Times of Trenton repeatedly has pointed out in its frequent coverage of this tragedy.

While many of the WMD Commission's recommendations for improving biosecurity look sound on the surface, none of their specific action proposals are based on a detailed examination of how the 2001 anthrax attacks occurred. More than seven years after the attacks, many critical questions remain unanswered. Chief among them is why the Federal Bureau of Investigation's (FBI) "Amerithrax" investigation focused for so long on the wrong suspect.

The FBI's performance in the wake of the attacks has left me and many other Americans wondering whether the Bureau is truly equipped to handle bioterrorism. Deterring such attacks in the future depends in part on at least the expectation of swift and certain detection and punishment.

Neither happened in the case of the 2001 anthrax attacks. We need to know why the first attack succeeded and why the perpetrator or perpetrators escaped justice.

Just as the 9/11 Commission looked not only at the attacks of that morning, but also at recommended changes in the structure of government agencies, screening methods and even congressional oversight, so should an anthrax commission look at the specific crime, but also at measures for prevention, detection and investigation of any future bioterrorism.

An anthrax attack investigation would help address these kinds of policy questions in a level of detail that the WMD Commission could not.

Rep. Rush Holt, D-Hopewell Township, is chairman of the House Select Intelligence Oversight Panel.

FBI Press Release details the meaning of the ASM presentations in Baltimore last week--with comments

For Immediate Release
March 6, 2009

Washington D.C.
FBI National Press Office
(202) 324-3691

FBI Responds to Science Issues in Anthrax Case

FBI Laboratory Director D. Christian Hassell, PhD issued the following statement:

During a recent American Society for Microbiology Biodefense (ASMBD) meeting in Baltimore , Maryland , questions were raised regarding two scientific analyses conducted during the course of the anthrax investigation. While this information is not new, it is important for the FBI to clarify the science since these findings continue to be misinterpreted by various media outlets.

The first item involves the elemental analysis of the anthrax spores that was conducted by Dr. Joseph Michael, a materials scientist at Sandia National Laboratories. At the conference, Dr. Michael presented analyses of three anthrax letters (Leahy, Daschle, and New York Post). He concluded that the anthrax powder in the three letters shared a chemical fingerprint but did not match the chemical fingerprint of spores in Ivins’ flask. Spores from the letters showed a distinct chemical signature that included silicon, oxygen, iron, tin, and other elements. Spores from Ivins’ RMR-1029 flask did not contain those elements in quantities that matched the letter spores. This is not unusual considering that Ivins’ RMR-1029 preparation had been submerged in water and other chemicals since 1997 and was a mixture of 34 different spore preparations. The letter spores were dried spores, produced from two separate growth preparations as indicated by differences in the New York and Washington, D.C. mailings. Although the chemical fingerprint of the spores is interesting, given the variability involved in the growth process, it was not relevant to the investigation.

It is important to note that the genetic profile of the spores from the letters and the spores from Ivins’ RMR-1029 flask was identical. Ivins’ RMR-1029 spore preparation had the same combination of anthrax mutations found in the letters. Only eight of the anthrax samples collected during the course of the investigation matched the genetic profile in the letter material and all were linked back to RMR-1029. This conclusion was the most significant and relevant scientific finding in the case.

By analogy, if one were to grow a corn stalk from a specific corn seed, the trace chemical fingerprint of the stalk might differ from that of the seed due to different compositions—for example iron—in the respective fertilizers used to grow each; however, the genetic profile of the seed and the stalk would be identical.

The second item involves isotopic analysis of the mailed anthrax. Media reports indicated that FBI scientists had concluded in 2004 that out of many domestic and foreign water samples analyzed only water from near Fort Detrick, Maryland, where Dr. Ivins worked, had the same isotopic signature as the water used to grow the mailed anthrax. This statement is incorrect. While water isotopic analysis was researched, the FBI concluded that there were too many confounding variables to precisely match bacteria that were grown using different materials and recipes. This technique was not relevant to the investigation.

While we have full confidence in our scientific approach, an additional independent review will provide further validation and thus benefit the larger scientific community. Consideration of an outside review began before any public disclosure of the scientific aspects of the investigation. This follows our approach throughout the investigation: to bring in external scientists to review and provide advise on our methodologies.

Nass comments: Even if everything stated above is accurate, the FBI has yet to prove that Ivins himself, not just his flask, provided the parent spores for the anthrax letters.

-- How did the FBI "rule out" as perpetrators over 100 other people who had access to spores from Ivins' flask?

-- How did the FBI ascertain that all of the secondary spore collections, derived from the flask, were 100% secure and could not have been surreptitiously obtained by others?

-- How was the FBI sure that no one else received spores from Fort Detrick, given that Fort Detrick's inventory problems were serious enough for there to have been a temporary "stand-down" of research just last month? Also consider that Ivins' flask was in a separate building from his lab, to which others had access, for over a year.

Since a thorough, complete accounting of its six year long, resource-intensive investigation has yet to be provided by the FBI, the following questions (raised by Representative Rush Holt on October 16, 2008) are additionally relevant:

"Are any of the FBI’s scientific findings inconsistent with the FBI’s conclusions?

Are there any scientific tests that the FBI has not done that might refute their conclusions?

Did the FBI follow all accepted evidence-gathering, chain of possession, and scientific analytical methods? Is it possible that any failure to do so could have affected the FBI’s conclusions?

Is it scientifically possible to exclude multiple actors or accessories?"

It is now 7 months since FBI announced the case was closed. During that time, FBI has released many pieces of (selected) evidence. The latest release, at a special ASM meeting convened for the purpose, was designed to make the scientific case.

The FBI charade has failed. The most basic questions remain unanswered.

Israeli Ministries take 'full responsibility' for anthrax vaccine trials

Article in THE JERUSALEM POST
Mar. 4, 2009
Yaakov Lappin

The Defense Ministry, Health Ministry and IDF said they took "full responsibility" for all side effects suffered by participants in a test of an anthrax vaccine, in a joint statement issued Wednesday.

The statement will be submitted to the High Court next week as a reply to petitions submitted by two IDF soldiers who took part in the trial and suffered negative aftereffects.

The petitioners raised questions about the way the vaccine trial was conducted, and are claiming the monitoring of volunteers and subsequent care provided to them was inadequate.

The vaccine trial, code-named Omer 2, took place between 1998 and 2006, and sought volunteers from elite IDF units. Following the test, a number of participants complained of breathing problems and skin conditions.

A quarter of participants were given an American version of the vaccine, while 75 percent were injected with the Israeli vaccine, which had not been previously tested. Members of both groups suffered side effects.

According to the statement, which was released by the Defense Ministry, 716 soldiers took part in the trial, and 11 later required medical treatment.

"Volunteers were given a detailed explanation about the vaccination, the study, and potential side effects. They were given a sheet to study and sign," the statement said.

"All of the soldiers who requested medical care received it," it added.

The Defense Ministry went on to describe Omer 2 as a project with "strategic importance for the State of Israel," adding, "Thanks to Omer 2, Israel has a medical response for the general public against a most severe threat. We thank the volunteers and appreciate their willingness to take part in this important trial, and their contribution to the general security of residents of Israel."

The vaccine is as safe as the anti-anthrax vaccine developed by the US, the Defense Ministry said.

Academic experts and oversight committees within the IDF closely monitored the vaccine trial, the statement added.

Remembering the anthrax attack

Glenn Greenwald's March 4, 2009 Salon article on Representative Rush Holt's bill and the ramifications of the anthrax attack is a must-read. Great links. Here is an excerpt:

The ultimate establishment organ, The Washington Post Editorial Page, issued numerous editorials expressing serious doubts about the FBI's case against Ivins and called for an independent investigation. The New York Times Editorial Page echoed those views. Even The Wall St. Journal Editorial Page, citing the FBI's "so long and so many missteps," argued that "independent parties need to review all the evidence, especially the scientific forensics" and concluded that "this is an opportunity for Congress to conduct legitimate oversight."
In the wake of the FBI's accusations against Ivins, the science journal Nature flatly declared in its editorial headline -- "Case Not Closed" -- and demanded an independent investigation into the FBI's case. After the FBI publicly disclosed some of its evidence against Ivins, The New York Times reported "growing doubts from scientists about the strength of the government's case." The Baltimore Sun detailed that "scientists and legal experts criticized the strength of the case and cast doubt on whether it could have succeeded." Dr. Alan Pearson, Director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Proliferation -- representative of numerous experts in the field -- expressed many of those scientific doubts and demanded a full investigation.
There may be legitimate grounds for doubting whether an independent, 9/11-type Commission of the type Holt proposes is the ideal tribunal to conduct a real investigation, but it is clearly the best of all the realistic options. The only other plausible alternative -- an investigation by Congress itself -- is far inferior, as anyone who has observed any so-called "Congressional investigation" over the last decade should immediately recognize (here, as but one example, is the account I wrote about a House hearing last September attempting -- with cringe-inducing ineptitude and total futility -- to "grill" FBI Director Robert Mueller about the FBI's case against Ivins). How effective an independent investigative Commission like this will be will depend on the details of its structure -- its subpoena powers, punishments for defiance, and the independence of its members. That Rush Holt will play a key role, if not the key role, in overseeing its creation is a reassuring feature that the bill he introduced can be actually productive.

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

For Immediate Release Contact: Zach Goldberg March 3, 2009
202-225-5801

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

Bill Would Create 9/11 Commission-Style Panel to Investigate Anthrax Attacks and Government Response

(Washington, D.C.) – Rep. Rush Holt (NJ-12) today introduced the Anthrax Attacks Investigation Act of 2009 (HR 1248), legislation that would establish a Congressional commission to investigate the 2001 anthrax attacks and the federal government’s response to and investigation of the attacks. The bipartisan commission would make recommendations to the President and Congress on how the country can best prevent and respond to any future bioterrorism attack. The attacks evidently originated from a postal box in Holt’s Central New Jersey congressional district, disrupting the lives and livelihoods of many of his constituents. Holt has consistently raised questions about the federal investigation into the attacks.

“All of us – but especially the families of the victims of the anthrax attacks – deserve credible answers about how the attacks happened and whether the case really is closed,” Holt said. “The Commission, like the 9/11 Commission, would do that, and it would help American families know that the government is better prepared to protect them and their children from future bioterrorism attacks.”

Under Holt’s legislation, the commission would be comprised of no more than six members from the same political party. The commission would hold public hearings, except in situations where classified information would be discussed. The commission would have to consult the National Academies of Sciences for recommendations on scientific staff to serve on the Commission. The Commission’s final report would be due 18 months after the Commission begins operations.

“Myriad questions remain about the anthrax attacks and the government’s bungled response to the attacks,” Holt said. “One of the most effective oversight mechanisms we can employ to get answers to those questions is a 9/11 style Commission.”

Examining Other Healthcare Models

Healthcare is highly valued by our society, yet it seems that many of our pundits and politicians are willing to create a new healthcare system from whole cloth. In other words, let's consider this or that experiment, and the winner will be the compromise melange that gets passed by Congress. (Definition of melange: a collection containing a variety of miscellaneous things.)

Well, we already experimented with the theory that government was the problem, tossing strict regulation (of banks, mortgage providers, stockbrokers, the food and drug industries, and military procurement, to name a few) in the wastebin, and where did it get us? Do we really want our healthcare system to be crafted by a bunch of horse-traders, and laden with pork?

I, for one, don't think we have the time or money for another major social experiment. I think it is time to put the available information to work to craft a system that we know will meet our needs, before we put it into place.

So far, there has been deafening silence on the subject of healthcare systems in the rest of the world, and what is wrong and right with them. Yet these models can tell us so much about how different programs are likely to work. We should be examining the other systems under a microscope right now, as the administration and Congress begin taking positions.

Thankfully, blogger Tim Foley at Change.org has begun this conversation, describing how a low-cost, high tech, high drug use system has led to enviable life expectancy and infant mortality rates in Japan. Enjoy his enlightening piece.

NY Times "Postscript" to Scott Shane's article on Ivins of Jan 4, 2009

A two-paragraph article in today's NY Times, sans byline, appears to end discussion of the so-called "chemical signature" said to identify the source of water used to grow the anthrax letter spores:

On Tuesday at an American Society for Microbiology conference in Baltimore, an F.B.I. scientist, Jason D. Bannan, said the water research ultimately was inconclusive about where the anthrax was grown. An F.B.I. spokeswoman, Ann Todd, said on Wednesday that the bureau “stands by the statements” of Dr. Bannan.

It is a postscript to Scott Shane's major article on Bruce Ivins dated January 4, 2009, which reported that a "chemical signature" of the water in which spores were grown pointed to Fort Detrick, Md.

Revealed: Scientific evidence for the 2001 anthrax attacks

from an article by Debora MacKenzie, who has been knowledgeably reporting on anthrax and bioterrorism at the New Scientist for more than a decade:

. . . Next the team developed highly sensitive tests to screen all 1072 samples for four of the mutations. Eight samples had all four. One came from a flask labelled RMR-1029 that Ivins was responsible for at USAMRIID. The other seven came from cultures taken from that flask, only one of which was not located at USAMRIID. So while these findings show the attack spores came from one of these cultures, the FBI has gone further in concluding the attack came directly from the RMR-1029 flask.

Another question is how the attacker turned the water-based slurry of spores in the flask to the fine, dry powder in the letters. . .

How to Heal the Ailing FDA

Six spot-on suggestions from Steve Nissen, MD to the Obama administration.

Anthrax investigation still yielding findings: Chemical composition of spores doesn't match suspect flask.

Nature article by Roberta Kwok discusses the American Society for Microbiology's Biodefense and Emerging Diseases Research Meeting in Baltimore, Maryland on February 24, 2009. Excerpt:

Joseph Michael, a materials scientist at Sandia National Laboratories in Albuquerque, New Mexico, presented analyses of three letters sent to the New York Post and to the offices of Senators Tom Daschle and Patrick Leahy. Spores from two of those show a distinct chemical signature that includes silicon, oxygen, iron, and tin; the third letter had silicon, oxygen, iron and possibly also tin, says Michael. Bacteria from Ivins' RMR-1029 flask did not contain any of those four elements. . .

NICE on Mars

Merrill Goozner discusses a BMJ article by Nigel Hawke about Britain's National Institute for Health and Clinical Excellence, and how it might help those of us in the less-regulated medical world to get useful information on pharmaceuticals. Excerpts:

The global pharmaceutical industry considers Great Britain's National Institute for Health and Clinical Excellence (NICE) about as welcome as salmonella-tainted peanut butter at a Super Bowl party.

NICE has used independent researchers to compare the effectiveness of new drugs (especially cancer drugs) to what's already available. It then proceeds to establish their value by measuring how much they extend life and wellbeing (the dreaded cost-effectiveness analysis, also independently derived). Finally, the agency provides the information to England's National Health Service, which uses it to determine what services it can provide through its limited budget.

Great Britain also has longer life expectancy, lower infant mortality and health care costs about 60 percent of what we pay in the U.S.

NICE may export its model for profit to -- oh, double the horror -- the U.S. "It's clear that what we do and how we do it is of interest to healthcare systems around the world, regardless of how they are funded," NICE chief executive Andrew Dillon told BMJ.

Good for Business, Bad for Patients?

Excerpts from Dr. Jon Abramson's ABC News Op-Ed:

It's perfect. Pfizer buys Wyeth's pipeline, the behemoth marketing power of Pfizer gets leveraged, the work force gets consolidated and the $22 billion borrowed is read as a sign that banks are willing to lend again...

The core problem with American medicine isn't really access or cost. It's that medical knowledge itself has been turned into a commodity, produced and disseminated with the primary goal of optimizing profits rather than health...

What we've got is a good old-fashioned case of market failure. But understanding the magnitude and consequences of the failure of the market to oversee the relevance and integrity of commercially generated medical knowledge is virtually impossible to see unless you're a corporate insider or have a subpoena to gain access to the unspun scientific evidence (closely held as proprietary information by the drug companies) and other corporate documents...

More pictures +/- the complete exosporium

Here (or here, if you are having trouble viewing the first set of images) is a side by side comparison of the Sandia pictures (from Anonymous) with pictures of 2 different batches of anthrax spores from another paper. One picture shows anthrax spores WITH an intact exosporium, the other WITHOUT an intact exosporium. Clearly the Sandia picture most resembles the one WITHOUT an exosporium. This contradicts Sandia's claim that their picture of the mailed spores has an intact exosporium.

More on health financing (NYT Blog): How Do Hospitals Get Paid? A Primer

Wonderful article by economist Uwe Reinhardt clarifying bizarre hospital charges and third-party reimbursements, and how much of the healthcare dollar they waste. Excerpt:

Americans can be forgiven their ignorance on this issue because, as I put it in a recent paper on the subject, the pricing of hospital services is best described as “Chaos Behind a Veil of Secrecy.”

Army releases some e-mails from anthrax suspect/Frederick News-Post

Article by Justin Palk

The U.S. Army released 33 pages of Bruce Ivins' e-mails Thursday from his account at Fort Detrick.

The e-mails, obtained by The Frederick News-Post under the Federal Freedom of Information Act, span the period from September 1998 through January 2002.

The documents contain 16 threads of communication, some including multiple e-mails between Ivins and his correspondents.

The e-mails all address one of three issues: the work of Ivins and other individuals to plan an international meeting of anthrax researchers in Annapolis for the summer of 2001; discussions of lab research; and in two cases, copies of The New York Times articles about the investigation into the 2001 anthrax mailings that Ivins e-mailed to himself.

The news articles both concern the difficulty investigators had early on in tracking the history and origins of the Ames strain of anthrax used in the mailings.

The Army continues to review additional e-mail messages from Ivins.

In August, the Department of Justice announced it considered Ivins, a U.S. Army Medical Research Institute of Infectious Diseases microbiologist, its sole suspect in the 2001 anthrax mailings that killed five and hospitalized 17 others.

Ivins died on July 27 after intentionally overdosing on acetaminophen.

His attorney has maintained Ivins was innocent.

Defense attempting to block report about anthrax trial/Haaretz

Excerpts from the article:

... IDF soldiers were given seven doses of an anti-anthrax vaccine developed by the Nes Tziona biological institute. But there was no extended medical supervision of the vaccinated soldiers.

A year and a half ago, a group of soldiers vaccinated in the experiment asked the IDF and Defense Ministry for all the details of the experiment, saying they suffered from debilitating side effects. The army and Defense Ministry ignored the request and would not recognize the soldiers as disabled veterans - eligible for benefits from the IDF.

Fixing the financial incentives in medicine

Medco (this is the pharmacy benefits company that settled for $155 million over charges of defrauding the federal government and paying kickbacks in 2006) manager Dave Snow has jumped into the healthcare debate. His idea is to force doctors to prescribe pre-selected treatments: if you diagnose A, you treat with B.

Obviously, Mr. Snow doesn't understand why medicine is an art. You have to take into account preexisting illnesses, risk factors, other medications, drugs allergies, drug intolerances, likelihood of compliance, and patient psychological, social and too often, financial factors to come up with a treatment. And then you should negotiate it with the patient to increase compliance and understanding. That is why B is often not the best choice. (Medco may not even offer B on its formulary, which is an additional reason to choose C.)

Granted, there are numerous problems with our medical system, and there are many possible solutions. In contrast to Mr. Snow, let's look a little deeper at why we have so many problems:

1. The financial incentives are all wrong.

a) You don't get paid more for getting things right: you get paid more for ordering more tests, increasing the number of visits, and spending the shortest possible time with the patient. Four fifteen minute visits pay almost twice as much as one hour-long visit. Spend an hour performing a detailed evaluation of a complex patient, get the diagnosis right and bingo! you have just forfeited reimbursements for additional visits, as well as earning considerably less for the hour you just spent than if you had seen patients with 4 sore throats.

b) You don't get paid for keeping people well, in general.

c) Outcome measures are rudimentary. Doctors are currently graded on whether a sufficient proportion of patients have regular mammograms, PAP tests and vaccinations, and whether their patients with chest pain receive appropriate emergency medications. But these measures indicate nothing about the proportion of correct diagnoses, or patient satisfaction. And they may incentivize bad behaviors. For example, the reasonable requirement to give all patients with pneumonia an antibiotic within 4 hours of ER arrival led to excessive antibiotic prescribing in every patient who "might" have had pneumonia.

d) Primary care docs are paid very little relative to docs who perform procedures. Procedures rule medicine. High profit procedures like cardiac catheterizations, neurosurgery, orthopedic surgery, and endoscopy subsidize ordinary patient care in hospitals and clinics. Hospitals pay hospitalists considerably more than they can bring in (in reimbursements from third party payers), in part because hospitals cannot function without them, but also because these primary care doctors order more lucrative tests and procedures on their patients.

e) Due to concerns about malpractice and meeting patient expectations (most patients expect that everything that can be done for them, will be done) doctors order more tests and procedures than are justified by existing guidelines.

f) The medical literature is contradictory on an enormous number of medical issues, so doctors are hard-pressed to trust the literature to give them the best or most accurate answers...leading to increased testing and procedures, since our culture punishes sins of omission much harder than sins of comission, or "doing too much."

g) The negative results of "doing too much" fail to be acknowledged or quantified. How many cancers are caused by unnecessary CT scans? I have no idea. How many patients die after undergoing cardiac catheterizations, when a medication adjustment might have been as effective? Studies of such questions fail to be published in major journals and do not appear to have affected clinical practice.

h) Professionalism currently demands from doctors that they meet the "standard of care" provided by other local practitioners. In part because the medical system is so complex, and there are so many medical tests, procedures and specialties, our expectation of ourselves as practitioners is more about ordering the right test and referring to the right specialist, rather than correctly diagnosing the patient. We expect that the test or the specialist will provide the answers if we do not have them. Cognitive skills have been devalued.

There is little financial or professional incentive to keep studying and struggling to find answers for the most challenging patients. And no financial or other reward if you succeed.

More later...

Coated and uncoated spores may look alike

Pictures of coated and uncoated spores are here, courtesy of Anonymous.

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

Global Security Newswire article
National Journal Group

Friday, Jan. 16, 2009
By Elaine M. Grossman

WASHINGTON -- The Food and Drug Administration violated its own regulations three years ago in approving the anthrax vaccine to prevent infection by a "weaponized" form of the disease, attorneys for eight Defense Department employees alleged in a brief filed last week at the U.S. Court of Appeals (see GSN, March 3, 2008).

(Jan. 16) - The anthrax vaccine received approval in late 2005 as a protective measure against inhaled anthrax (Emergent BioSolutions photo).

The Pentagon began a vaccination program for more than 1 million service personnel in 1998, during the Clinton administration, and continued the effort under President George W. Bush. However, compulsory shots were suspended from late 2003 through early 2007, after a federal judge found the Pentagon lacked the legal authority to compel inoculations for an unapproved use of the vaccine.

Critics have voiced concern that it is unclear how useful anthrax vaccine is in preventing the highly lethal disease from being contracted through inhalation, and have called attention to the possible risks associated with giving the inoculations to a large population.

The U.S. government recently moved to shield itself from liability in distributing the vaccine in the event of a bio-warfare attack, just as a key advisory panel to the Centers for Disease Control and Prevention approved extending the shots to emergency first-responders nationwide (see GSN, Oct. 17, 2008, and Oct. 23, 2008).

A December 2005 FDA ruling allowed a vaccine previously labeled for use solely in inhibiting anthrax contracted through the skin or the digestive system to also be administered to prevent acquiring the disease via the lungs.

The decision paved the way for the Defense Department to resume mandatory inoculations for service members whose assignments are believed to put them at increased risk of exposure to anthrax during a potential biological attack (see GSN, Sept. 5, 2007).

However, two attorneys who succeeded in temporarily shutting down the mandatory shots program in 2003 remain dissatisfied. They alleged in a second lawsuit, filed in December 2006, that the Food and Drug Administration had not followed its own standards for reviewing a vaccine for approval in issuing its 2005 go-ahead.

The result, they are alleging, is that the vaccine has not been shown to be safe and effective for preventing inhaled anthrax.

U.S. District Judge Rosemary Collyer last year ruled against the plaintiffs, saying the court "will not substitute its own judgment when the FDA made no clear error of judgment."

Plaintiff attorneys Mark Zaid and John Michels took their case to federal appeals court, and the 73-page brief filed last week constitutes their written argument.

"There are ... internal inconsistencies in the [FDA-reviewed] record showing that nobody believed this vaccine was adequate for preventing inhalation anthrax until the DOD decided they were going to conduct this mass inoculation," Michels said in an interview yesterday. "The FDA's failure [in its 2005 action] to explain all of these contradictory statements [in] their own documents is a violation of the Administrative Procedures Act."

The 1946 federal law controls how government agencies draft and issue regulations.

A Defense Department spokesman praised the federal judge's decision.

"We owe it to our service members to give them every possible protection," Bryan Whitman said last year. "Force protection is the No. 1 priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."

In their Jan. 7 brief to the U.S. Court of Appeals, though, Michels and Zaid took issue with the notion that the vaccine has been proven to protect humans from contracting inhaled anthrax.

If the court invalidates the FDA authorization for this use, the Defense Department could be required to obtain informed consent from any personnel receiving the five-shot series (see GSN, Dec. 22, 2008).

In the case, called Rempfer vs. von Eschenbach, the two lawyers are representing Thomas Rempfer and seven other Defense Department personnel ordered to take the vaccines. Defendants are led by FDA Commissioner Andrew von Eschenbach and include the health and human services and defense secretaries.

"The regulatory history of the [anthrax vaccine] was nothing if not convoluted and contradictory," according to the plaintiffs' new court submission. "The main basis" for Collyer's decision to dismiss the case "was the FDA's reliance on a single human test of [the anthrax vaccine] that occurred more than 50 years ago, using an admittedly different vaccine," the complainants stated.

The district court judge's Feb. 29, 2008, decision "ignored the significant disparities" in vaccine testing as well as plaintiff allegations that "undercut" the key medical study's "validity and scientific basis," the brief reads.

"We are alleging," Michels told Global Security Newswire, "the FDA has not done its job."

Agency records show a "significant failure by FDA to follow its own procedures with regard to licensing of the current version of the vaccine using data from a vaccine that was manufactured using different standards, a different anthrax strain, and different methodology," according to the brief. "The District Court's simple acceptance of the representations made by the government was improper and factually unsupportable."

An FDA spokeswoman today declined to offer comment on the court case.

Pending a possible extension in due date, the government has 30 days to issue its own written brief for the appeals court. After that, the plaintiffs will have an opportunity to submit their response. The appeals panel may then request to hear oral arguments on the case before issuing its decision.

Critique of the "chemical signature" assertion and other points by Barry Kissin

Barry Kissin, an attorney in Frederick, Maryland, analyzes several assertions in Scott Shane's January 4 article, by reviewing media and other reports published since 2001. These include the unsupported claim that the "chemical signature" of the water used to grow the letter anthrax could only come from Frederick, Maryland, and that other US government and quasi-governmental biodefense laboratories have been ruled out as sources.

Frederick Police Report out

The Frederick Post has made available a pdf of the Frederick Police Department report regarding its investigation of Ivins' last days.

I have several questions after reading this material. First, I would assume that Ivins made two trips to the Giant Eagle pharmacy an hour apart in order to drop off prescriptions then pick up the medications. The police report claims he purchased one bottle of 70 tylenol pills. Scott Shane said he purchased two bottles of tylenol PM, which includes benadryl, one during each visit to the pharmacy. Prior reports (and one mention in this police report) indicated he ingested tylenol with codeine, which would have required a prescription, and does not appear to have been purchased on July 24.

Thus it still remains unclear what he purchased, what he had available at home, and how much tylenol (and other substances?) he may have ingested. There should have been investigations of the contents of the orange soda and red liquid found in Ivins' bathroom and bedroom, respectively, but the police report fails to indicate whether these materials were collected and studied.

Second, Ivins' disclosure to the Red Cross of his medical history provides support for the hypothesis that Ivins suffered from chronic medical problems that are commonly found in patients who become ill following receipt of anthrax vaccinations. He reported chronic pain issues ("back/joint/bone problems" for which he took neurontin, lidocaine patches, aleve and diazepam); psychiatric issues ("anxiety/PTSD/Bipolar Disorder" and "depression"); and sleep apnea.

All 3 are among the most common symptoms that occur as sequellae of anthrax vaccine, as noted by me but also by the Vaccine Healthcare Centers Network, which screens many patients for sleep apnea. This diagnosis is relatively rare in thin males, but has occurred in 80% of those disabled males I have evaluated in the past 3 years for the sequellae of anthrax vaccine. All those patients had chronic widespread pain disorders and psychiatric sequellae as well.

Third, Ivins had rhabdomyolysis and (probably secondary) renal failure when he arrived at the ER, in addition to the subacute sequellae of liver failure (presumably from a tylenol ingestion). It is not clear what led to his developing this, which seems to have significantly added to the severity of his final illness. Release of more medical information would help clarify whether the known facts fully explain the medical consequences Ivins experienced.

NYT: Portrait Emerges of Anthrax Suspect’s Troubled Life

Scott Shane's newest, detailed exploration of Bruce Ivins can be summarized in Shane's statement, "unless new evidence were to surface, the enormous public investment in the case would appear to have yielded nothing more persuasive than a strong hunch, based on a pattern of damning circumstances, that Dr. Ivins was the perpetrator."

Let me make a few comments on this very detailed story.

...anthrax specialists who have not spoken out previously said that, contrary to some skeptics’ claims, Dr. Ivins had the equipment and expertise to make the powder in his laboratory.

He may well have--but this begs the bigger question of how long it would have taken and whether he could have done so without being detected.


And most importantly:

The science alone could not close the case. “We could get to a lab, to a refrigerator, to a flask,” said Dwight E. Adams, the F.B.I. laboratory director until 2006. “But that didn’t put the letters in anyone’s hand.”

As the bureau’s undercover informant, Dr. Haigwood struck up a breezy e-mail correspondence about scientific grants, pets and travel. Dr. Ivins complained about psychological screening and other “rather obnoxious and invasive measures” imposed at Fort Detrick since the anthrax attacks.

Dr. Nancy Haigwood believed Ivins was the culprit and had additionally, "damaged my property, he impersonated me and he stalked me.” She was afraid he would send her an anthrax letter. Her goal in renewing their friendship was to get him to incriminate himself. So any evidence resulting from their correspondence would need to be viewed from this perspective and in its entirety.

Dr. Ivins still carried resentment from four decades earlier at Lebanon High School in Ohio, where he had been a nerdy, awkward teenager devoted to photography and, even then, to the study of bacteria.

What percent of Ph.D. scientists did not feel nerdy, awkward and excluded as teens, I wonder? (I do not mean to target scientists. The teen years are awkward for most people.)

Though a public debate had raged for years over whether the mailed anthrax had been “weaponized” with sophisticated chemical additives, the F.B.I. had concluded early on that it was not.

The jury is still out on this issue, but many believe otherwise.

By 2004, secret scientific testing established that the mailed anthrax had been grown somewhere near Fort Detrick.

Presumably this comment refers to properties of the water used to grow anthrax; whether such analysis can reliably pinpoint the Frederick, Maryland area remains open to question.

Rockefeller vows fight on Gulf War syndrome

Excerpted from an article in the December 29 Charleston, W.V. Daily Mail:

.... The senator said it was shameful that neither the Department of Defense nor the Department of Veterans Affairs acknowledge Gulf War syndrome as a real illness.

"We were stonewalled by the DOD in hearing after hearing after hearing," Rockefeller said of several meetings on the issue since the early 1990s. "They thought we were wrong, crazy, and came up with some kind of cockamamie theory. No matter what we produced, they'd send it back and call it nonsense..."

"My attitude is that we should never stop fighting until they get the money and benefits they need," Rockefeller said. ... he'd continue to push for those veterans as a member of the Senate Veterans Committee. He also is set to begin his tenure as chairman of the Senate Commerce Committee."

Correction:

There are 2 errors in what I posted below about the forensic analysis discussed in Professor Jacques Ravel's slides. The first correction is that the over 1,100 samples submitted to the FBI were screened for genotypic differences, and may not have been screened for morphologic differences.

The second error is that the slides say wild-type Ames (isolated from a heifer that died in Texas in 1981) did not vary from an anthrax sample isolated from Bob Stevens' cerebrospinal fluid (over 5 million base pairs identical), rather than from the anthrax letters directly.

What I termed slide 16 has a list of 5 different isolates (morphotypes) from the Leahy letter and 3 from the NY Post letter. One of each is termed "wild-type" so you might say there are 4 (Leahy: A, B, C and E/Opaque) and 2 (NY Post: A and B) morphotypes distinct from the majority colony type listed on the slide.

Later the slides indicate that 3 genotypes were identified within the A morphotype. The slides do not indicate how many genotypes were found in the other morphotypes. Nor how these were determined. There are 2 slides on each page. So what I identified as slide 16 is actually page 16, slide 31.

Slide 45 indicates that 4 PCR assays were developed to distinguish genotypes. I don't know from which samples these distinctive genotypes were found, and used.

The over 1100 submitted samples were screened for PCR genotype differences. Some had 1 or 2 variants but only the sample from Ivins' flask had 4. (It is implied that 4 were found in the anthrax letters.)

BOTTOM LINE:

I erred in mixing up morphotypes and PCR assays in my earlier statement. There is nothing in the slides that indicated the 1100 samples were screened for morphologic colony differences.

There is missing information so I cannot say what kinds of samples were used to discern the genotypic differences. But my guess is these were genetic differences within morphotypically distinct colonies.

However, the slides appear to indicate that the morphologic variants differed between the two letters.

If genotypic differences of rare morphotypes are what was used to nail Ivins' flask, the science may be questionable. If the morphotypes varied between the two letters, is it forensically valid to focus on qualitative genotypic differences in a subset of morphotypes? But I am guessing this is what was done. The FBI needs to tell us precisely what methods were used.